1. Field of the Invention
The present invention relates generally to devices and methods for urodynamic evaluation, and more particularly, to such a system and method that utilizes micro-electronic mechanical system (MEMS) technology.
2. Description of the Prior Art
In order to treat urinary incontinence, it must first be understood which type of incontinence the patient is suffering from, and the physical causes for the incontinence. Many types of urodynamic systems and tests are currently available to try to assess the type and causes of incontinence. These systems can be broadly categorized in two ways: office based systems and ambulatory systems.
Office based systems are designed for use in a doctor's or clinician's office. Many of these systems involve invasive testing using catheters and the like. Ambulatory systems are designed to capture data outside the office over a longer period of time, such as 1-2 days.
Known ambulatory systems for urodynamic measurements are also invasive in that they use catheters to capture pressure data within the urethral tract or in the bladder. It is readily apparent that such known ambulatory systems are uncomfortable and invasive for the patient. Further, because the catheters are inter-dwelling, they are prone to movement or migration over time as the patient moves around. In addition, they may not accurately capture typical daily occurrences, as the patient is, due to the discomfort, prone to move less and engage in fewer activities than normal while undergoing the assessment. Finally, the invasive catheters may also interfere with true physiological responses, as they can irritate the internal tissues/organs through which they are inserted. Thus, migration of the pressure sensors and their invasive nature limits the reliability and usefulness of the data. Another ambulatory system describes implanting a device within the bladder of the patient, but retrieval of the device can be an issue.
U.S. patent application Ser. No. 11/043,830, filed on Jan. 26, 2005, having Michael R. Tracey and Anthony DiUbaldi as the named inventors, and entitled “System and Method for Urodynamic Evaluation Utilizing Micro-Electronic Mechanical System”, and further being published on Aug. 11, 2005 and being assigned Publication No. US2005/0177067A1, the disclosure of which is incorporated herein by reference, describes an implantable urodynamic system for implanting within a patient's body. It includes two implantable devices. The first device, sized for implantation within a patient's bladder, includes a power source, at least one sensor for sensing a physiological property within the bladder, and a data storage element for storing data representing the physiological property sensed by the sensor. The first implantable device also includes a collapsible housing. The collapsible housing has a collapsed configuration sized for insertion through the patient's urethra and into the patient's bladder, and an expanded configuration sized for insertion within the bladder, but to prevent its passage from the bladder into the urethra.
The system can also have a second implantable device sized for implantation within the patient's vagina. This device also has a power source, at least one pressure sensor for sensing pressure within the vaginal canal, and a data storage element. In addition, it has a data retrieval device for retrieving and manipulating data from the first and second data storage elements once the devices are removed from the body. This second implantable device is encapsulated within a pliable casing, such as cotton, dimensioned to hold the device against the vaginal walls.